Betahistine intranasal - Otifex Therapeutics

Drug Profile

Betahistine intranasal - Otifex Therapeutics

Alternative Names: AM-125; Betahistine dihydrochloride nasal spray; Intranasal Betahistine

Latest Information Update: 24 Jul 2017

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At a glance

  • Originator University of Melbourne
  • Developer Otifex Therapeutics
  • Class Pyridines; Small molecules
  • Mechanism of Action Histamine H1 receptor agonists; Histamine H3 receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Phase I Otitis

Most Recent Events

  • 20 Jul 2017 Auris Medical Holding completes acquisition of intranasal betahistine from Otifex Therapeutics
  • 20 Jul 2017 Auris Medical plans an IND application with the US FDA for a phase II proof-of-concept trial in the first quarter of 2018
  • 20 Jul 2017 Auris Medical plans a phase I trial in Healthy volunteers in USA and Europe in the fourth quarter of 2017
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